The Staff Engineer, Systems is responsible for providing technical leadership in the design, development, integration, and validation of complex hardware and software systems for medical devices. This role leads system-level activities across user needs, architecture, requirements, risk management, usability, verification, validation, and regulatory compliance while providing technical direction and mentorship to cross-functional teams.
This position reports to the Director of Engineering and is part of the Engineering team located in Cincinnati, Ohio and will be an On-site role.
In this role, you will have the opportunity to:- Lead the development and lifecycle management of user needs, system requirements, traceability, and change control for complex medical device projects.
- Translate customer, clinical, business, and regulatory inputs into system architectures, technical requirements, integration plans, and verification strategies.
- Lead system-level design, product risk management, usability engineering, verification, and validation activities, including resolution of complex cross-functional technical issues.
- Provide systems engineering leadership throughout product development, commercialization, design transfer, manufacturing readiness, regulatory submissions, audits, and lifecycle management.
- Mentor engineers and advance systems engineering tools, processes, and best practices while contributing to project planning, resource management, and technical decision-making.
The essential requirements of the job include:- Bachelor's degree in engineering or a related field, such as systems, mechanical, or biomedical engineering.
- Minimum of 10 years of relevant engineering experience, including at least 5 years in systems engineering within the medical device industry.
- Demonstrated experience with requirements management, system architecture, risk analysis, usability engineering, and system verification and validation.
- Experience translating customer, clinical, business, and regulatory inputs into system-level requirements, architectures, and verification strategies.
- Experience providing technical direction to cross-functional teams and resolving complex system-level issues.
Travel, Motor Vehicle Record & Physical/Environment Requirements:- Ability to travel up to 15% of the time, including domestic and international travel and overnight, out-of-town assignments typically lasting 2 to 5 days.
- Ability to work in a typical office environment and occasionally visit laboratory, manufacturing, or clinical sites. Reasonable accommodations will be evaluated where needed.
It would be a plus if you also possess previous experience in:- Master's degree in engineering or a related field.
- INCOSE Certified Systems Engineering Professional (CSEP), Project Management Professional (PMP), or a comparable relevant certification.
- Mammotome, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $130,000 - $155,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
